Why the study?
Why did the FDA approve the 150-mg dose of dabigatran but not the 110-mg dose for reducing stroke and systemic embolism in patients with nonvalvular atrial fibrillation?
Population
Patients with nonvalvular atrial fibrillation
Comparison
Dabigatran 150-mg dose vs Dabigatran 110-mg dose
Design
Editorial
Key result
Dabigatran 150-mg was exclusively approved by the FDA to reduce stroke and systemic embolism in nonvalvular atrial fibrillation, despite the 110-mg dose also demonstrating effectiveness.
Authors
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FDA limits dabigatran to 150 mg for nonvalvular AF; leaves open individualized 110-mg use in high-bleeding-risk patients.
Why did the FDA approve the 150-mg dose of dabigatran but not the 110-mg dose for reducing stroke and systemic embolism in patients with nonvalvular atrial fibrillation?
The FDA approved only the 150-mg dose of dabigatran for stroke prevention in nonvalvular atrial fibrillation, determining that patients should receive the higher dose over the effective 110-mg alternative.
Beasley et al. (2011) studied this question. Dabigatran 150-mg was exclusively approved by the FDA to reduce stroke and systemic embolism in nonvalvular atrial fibrillation, despite the 110-mg dose also demonstrating effectiveness.